CHICAGO--(BUSINESS WIRE)--Chicago-based medical device firm Attune Medical has completed the final close of its Series C raise, now oversubscribed to total more than $15.5 million. This financing will be used to ensure Attune’s continued revenue growth in the worldwide temperature management market, along with expansion of Attune’s technology into emerging clinical applications such as hypothermia prevention during OR procedures, and to pursue further clinical studies and ultimately regulatory clearance for new clinical applications focused on reduction of esophageal thermal injury which can result from cryo- or radiofrequency-based cardiac ablation, a commonly used treatment for atrial fibrillation. The EnsoETM is the only patient temperature management system cleared for use in the esophageal environment for delivery of whole body temperature management.
Attune Medical’s Chief Executive Officer, Keith Warner, commented, “As the clinical use of temperature management gains a broader worldwide footprint in healthcare overall, Attune will continue to expand the application base for the EnsoETM toward novel, clinically impactful uses across a diverse array of clinical settings. We are well-positioned for continued growth in the critical care space, while also pursuing clinical evidence in support of new applications positioned to bring increased safety and efficacy to operating rooms and electrophysiology labs. This oversubscribed fundraising is a concrete signal of investor and market confidence in our mission to make temperature management as accessible and useful as possible for all clinical applications and patients who can benefit from this therapy.”
The EnsoETM (formerly Esophageal Cooling Device or ECD) is designed to modulate and control patient temperature through a single-use, fully-enclosed system that is inserted into the esophagus. Two lumens attach to an external heat exchange unit while a third, independent, lumen simultaneously allows gastric decompression and drainage, as well as the administration of enteral fluids such as tube feeds and medications in some models. The EnsoETM can be rapidly placed by most trained healthcare professionals, in similar fashion to a standard gastric tube, and can be used to control patient temperature in the operating room, recovery room, emergency room, and/or intensive care unit. No other products on the market are cleared for use in the esophageal environment for whole-body temperature modulation.
Formerly known as Advanced Cooling Therapy, Attune Medical has developed proprietary medical device technology that simplifies access to the patient’s core to efficiently control core temperature. Whether warming or cooling, the company’s technology platform optimizes, or “tunes”, patient temperature safely and effectively. Attune Medical (as Advanced Cooling Therapy) received US FDA de novo clearance for the EnsoETM (Esophageal Cooling Device or ECD) in 2015 for use with the Medi-Therm III by Stryker®. The company received FDA 510(k) clearance in 2016 for use with the Blanketrol® II and III Hyper-Hypothermia systems made by Cincinnati Sub-Zero, a Gentherm Company, and FDA 510(k) clearance for use with the Altrix System by Stryker® in 2017. The EnsoETM model for use with enteral feeding was cleared by the FDA in January 2018, with an additional clearance for use with Cincinnati Sub-Zero’s Norm-O-Temp Hypothermia System in May 2018. It received its CE Mark in Europe in 2014, with an expanded indication for use up to 120 hours in 2016 and a CE Mark for use with the Altrix System by Stryker® in 2017. It is also licensed for sale in Canada and Australia.